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Quality

Senior Manager/Associate Director, Clinical GCP Quality

  • Cambridge, MA
  • Added
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Position Overview:

Beam is seeking a highly talented and motivated Senior Manager / Associate Director – Clinical GCP Quality to join our growing Quality team. The Senior Manager / Associate Director – Clinical GCP Quality will be responsible for – quality aspects of Beam’s clinical studies and overall Good Clinical Practice (GCP) as the company grows and continues to evolve from a research and discovery (R&D) company to a broader organization moving products though the clinical pipeline to commercial launch and growth. Reporting to the Senior Director – Clinical GCP Quality, this position will be a key member of Beam’s Quality organization, as well as clinical study team(s) working with Clinical Development functional-area leads to ensure appropriate levels of clinical compliance and quality. Additionally, this position may assist Non-clinical Development (NCD) and Clinical Bioanalytics & Translational Sciences (CBTS) colleagues with qualification activities of third-party laboratories.

Responsibilities:

  • Assist the Senior Director – Clinical GCP Quality in helping to define and drive the clinical compliance and quality vision and mindset within the company.
  • Continue to improve/refine Beam’s risk based GCP compliance program as the company moves from developmental phase to phase (i.e., R&D, clinical research pipeline, commercial launch, growth).
  • Ensure appropriate quality systems are in place to qualify clinical and non-clinical suppliers, which may include laboratories conducting regulated activities (clinical and non-clinical), clinical sites, and clinical study-related documents as they relate to GCP compliance.
  • Oversee clinical compliance and quality within the context of a clinical study team(s).
  • Oversee quality aspects related to clinical study start-up, execution, and close-out by providing leadership, guidance, and direction to staff consistent with GCP.
  • Ensure appropriate escalation of significant issues that may impact patient safety, the reliability of clinical study results, product quality and/or supply, regulatory compliance, and/or company brand image.
  • May assist NCD and CBTS with qualification/requalification activities (questionnaires, audits, quality technical agreements, etc.).
  • May provide GxP auditing activities, including audit preparation, execution, report preparation, and follow-up to any findings/observations, including corrective and preventive actions (CAPAs).
  • May assist in preparation for health authority inspections at Beam, suppliers, and/or clinical sites.

Qualifications:

  • University degree in scientific discipline/life sciences OR equivalent experience in biotech or pharmaceutical industry.
  • 10+ years of relevant experience in a GCP (preferred) or related GxP environment with at least three years of demonstrated experience working with multi-disciplinary functional areas.
  • Solid knowledge of global regulatory requirements/standards for the pharmaceutical, biotech, or vaccine industry (experience in cell and/or gene therapies, a plus).
  • Positive approach.
  • Excellent interpersonal effectiveness and written/verbal listening/communication skills.
  • Excellent computer skills (quality and document management systems, clinical study-related systems (e.g., electronic data capture, interactive response technology, clinical trial management, etc.), and Microsoft products and services (e.g., Excel, PowerPoint, Visio, Word, etc.).
  • Highly attentive to details and able to work well as part of a team.
  • Demonstrates consistent quality, judgment, accuracy, speed, and creativity.
  • Takes initiative in making improvement suggestions to promote operational goals.
  • Applies quality concepts and company policies/standards to resolve issues of moderate complexity in an effective manner.
  • Facilitates designing processes with quality built in from the beginning.
  • Identifies and uses good judgment to handle out-of-compliance scenarios.
  • Ability to work independently.

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